There exists an ongoing need for the development and improvement of containers for the administration of IV liquids in chemical or drug therapies, nutritional supplements and blood transfusions. Particularly, in the field of chemical and drug therapies, the IV solution delivered to the patient often comprises a mixed combination of a diluent and one or more medicaments. In many cases, the medicaments must be maintained separately from the diluent until immediately before use to prevent degradation. Common packaging of the diluent and medicaments is often further complicated by the character of the medicament which may be a powder sensitive to moisture contamination, or a powder or liquid sensitive to degradation under light or oxygen exposure.
Numerous recent improvements in the technology of IV containers have been made providing flexible containers which are less easily damaged and more easily stored and handled. Containers such as that disclosed in U.S. Pat. Nos. 4,458,811 to Wilkinson and 4,608,043 to Larkin are representative of prior art multiple compartment flexible containers allowing separate storage of medicaments and diluents which may be mixed immediately prior to use. A second type of prior art devices provide a flexible diluent container with an attachment means for a second container containing a medicament and integral systems for engagement of the containers to maintain sterility while mixing the components.
Alternate systems in the prior art include combined containers wherein an inner container is physically manipulated from the exterior of a flexible covering container to release a medicament for mixing with a diluent in the flexible container. A vial contained within the flexible container having a plug or lid which may be extracted from the vial by manipulating the vial through the flexible walls of the container is exemplified in U.S. Pat. No. 4,610,684 to Knox et al. An additional alternative is provided in the prior art by pre-mixing the medicament and diluent and freezing the container until ready for use to extend shelf life by preventing degradation of the pre-mixed solution. The complexities and disadvantages are self evident of numerous and complicated parts for the containers or the added requirement for refrigeration support devices of these prior art approaches.
Further improvement over the prior art containers is desireable in that sealing mechanisms between compartmented containers such as that disclosed in Wilkinson have been complex and costly. Similarly, interconnecting devices for combination of two containers or for mechanical puncturing and interconnection of joined containers require numerous components which are expensive to fabricate and increase the possibility of failure. In addition, the dispensing configuration of prior art containers may preclude complete emptying of the container or require the presence of significant quantities of air in the container to allow complete delivery of the fluid contents of the container. Presence of significant quantities of air in the sealed container may produce difficulties during sterilization of the containers since air expansion at the sterilization temperatures may damage the flexible material of the container. Finally, configuration of multi-compartmented prior art containers has, in many cases, precluded assurance of complete mixing of medicaments with diluents prior to delivery to the patient.
It is therefore desirable to provide an IV container having multiple compartments for storage of diluent and medicaments in a single package having simple frangible seals dividing the compartments which may be ruptured for combination and mixing of the contents. It is further desirable that the container arrangement preclude the inadvertent delivery of any of the components prior to mixing and allow visual verification of condition of the components prior to mixing and after mixing is complete, before dispensing. It is also desireable that the contents of the container be completely deliverable to the patient without the requirement for the presence of a significant quantity of air in the container. The capability for enhanced protection of the contents in one or more of the compartments of the container against moisture or oxygen permeation or light degradation is also desirable.